EP3548127B1 - Atomizing unit with directly connectable ampoule - Google Patents

Description

The present invention deals with a nebulizer unit with an ampoule according to the preambles of the independent claims.

In order to treat respiratory and lung diseases, an effective medication must be delivered as completely as possible to the site of the disease, i.e. into the bronchi, alveolar ducts or the alveoli. For this purpose, a medication is usually prepared as a solution and finely atomized using a nebulizer before it is inhaled by the patient.

Common nebulizers known from the prior art, which are also available as mobile devices, consist of four essential components:
The heart of the nebulizer is the so-called nebulizer unit, which contains a micro-perforated membrane that is set into rapid oscillations by means of a vibration generator, usually a piezo crystal, usually in the ultrasonic range, whereby the medication solution that is directly applied to the membrane is pressed into the micrometer-sized holes in the membrane and is released on the exit side of the membrane as a mist of fine droplets. Usually the membrane is circumferentially annular Vibration generator directly without or indirectly with a support plate, mechanically coupled to form a coherent unit, the aerosol generator. Either a hose with a mouthpiece or a mouthpiece is placed directly on the nebulizer unit. A nebulizer also has a control unit that generates the signals necessary to control the vibration generator. On the supply side of the membrane, integrated into the nebulizer unit, there is usually a reservoir for the medication solution, which provides a sufficiently dimensioned cavity, which can usually be tightly closed by means of a cap, so that liquid present in the reservoir is not lost even when the nebulizer is being transported in a filled state goes.

An effective and comprehensible inhalation therapy places various demands on a nebulizer, especially with regard to hygiene and dosage.

Accurate dosage monitoring is important to ensure that the patient actually inhales a dose that is known to be optimal for highly effective medications that are usually administered via inhalation. A problem with this is that with conventional nebulizers the user has to measure the amount of liquid to be atomized or inhaled from a larger medication container and fill it into the reservoir. This can easily lead to inaccuracies. Even if the liquid is already measured in quantities suitable for inhalation, some of it can be lost when it is transferred from the medication container into the reservoir.

In order to avoid this, it was proposed to design the medication containers as ampoules, which can be inserted directly into an ampoule holder in the nebulizer unit. For example, the document discloses WO 02/074373 A1 a liquid supply system and a nebulizer equipped with it, consisting of a housing with an ampoule holder and a liquid receiving area. The corresponding ampoule has a plate at both the top and bottom ends, which leaves a well-defined opening in the ampoule when removed. Before insertion, the ampoule is first opened at the bottom end by breaking off the plate there, then inserted and only then is the upper plate removed to create a ventilation opening.

A disadvantage of this system is that if handled improperly by opening it outside the ampoule holder, the medication liquid can be contaminated by dirt or germs from the user. Furthermore, it cannot be completely ruled out that some of the medication liquid is lost before the ampoule can be inserted into the delivery system intended for it.

Those in the disclosure document DE 10 2005 038 619 A1 The invention described attempts to overcome these disadvantages by proposing an inhalation therapy device with an ampoule comprising an ampoule receptacle, in which the ampoule is inserted into the receptacle in the closed state and is only opened upon insertion by means of an opening device in the form of a mandrel.

As long as a sufficient sealing of the connection between the ampoule and the opening device is guaranteed, this is the case Losses of medication liquid are minimized and contamination by germs from the environment is also effectively prevented.

However, another problem regarding hygiene remains unsolved with this invention. In order to permanently ensure adequate hygiene, i.e. freedom from germs, nebulizers should always be cleaned and sterilized before each use. However, with the usually convoluted design of standard nebulizers, this is only possible to a limited extent effectively, meaning that after a certain period of use or a certain number of inhalation sessions, usually a few ten times corresponding to approximately one to a maximum of two weeks, germ-freedom is no longer sufficiently guaranteed.

One solution would be to replace the nebulizer, or at least the parts that cannot be sterilized sufficiently reliably, in particular the nebulizer unit comprising the aerosol generator, after this maximum safe period of use. However, this is problematic because nebulizer units known in the prior art, including and especially those disclosed in the publications mentioned above, are quite expensive due to their complex structure and are therefore a new purchase for the majority of users after the very short period of use of 1-2 weeks would be out of the question.

The patent specification DE 10 2008 054 431 B3 shows an aerosol therapy device with a holder for a medication ampoule, which is cut open when inserted by a mandrel surrounding a chamber located on the supply side of an aerosol generator, so that medication liquid flow from the ampoule into the chamber and can be nebulized there by the aerosol generator. The aerosol generator and cutting mandrel are assigned together to a base body, whereas the ampoule holder is arranged in a cover that can be detachably connected to the base body.

The disclosure document DE 10 2005 038 619 A1 discloses an inhalation therapy device with a nebulization device, to which medication liquid is supplied from an ampoule that can be cut open using an opening device. The ampoule is held in a receptacle in a detachably connectable lid of the inhalation device.

The published application document EP 2 062 608 A2 describes a disposable ampoule for use in an aerosol generating device.

In the publication document EP 2 987 520 A1 a liquid reservoir for a nebulizer and a nebulizer with such a reservoir are disclosed, the reservoir having a collar inside, through which an outer first and an inner second region are defined, whereby an amount of liquid reaching the aerosol generator is more or less independent of the orientation of the nebulizer. In some embodiments, the reservoir is in the form of an ampoule, which is cut open during insertion by a hollow mandrel located in a receptacle. When the ampoule reservoir is inserted, the hollow mandrel forms the collar and thus encloses the second area, which is delimited at the bottom by the aerosol generator. The aerosol generator is clamped between a front housing part that can be connected to a mouthpiece and a rear housing part comprising the receptacle and the mandrel.

The patent specification US 5,819,730 shows a device for administering pharmaceutical substances which are stored in liquid form in ampoules. The ampoules are opened by squeezing in the device, whereupon the medication liquid pressurized by the squeezing is squeezed out.

The published patent application US 2003/0140921 A1 describes a nebulizer in which ampoules are used.

The patent specification US 6,145,703 shows a spray applicator for multiple dose dispensing of medication liquid stored in a sealed container, which is pierced on the face by a hollow needle when inserted into a holder.

The international publication WO 96/28205 suggests a nebulizer with a precision dosing unit. The task that the present invention has set itself against this background is to develop a nebulizer unit which, with at least equal hygiene and dosing accuracy, allows user-friendly use and is simple and inexpensive to produce.

This task is solved by a nebulizer unit with an ampoule according to claim 1 and a method for its production according to claim 12.

An important idea of the present invention is to equip the ampoule with a connection area through which it can be directly and immediately connected to the nebulizer unit using the connection means of the ampoule holder. This does not rule out the possibility that ampoules that have a connection area that is not directly compatible with the connection means of the ampoule holder can be connected to the nebulizer unit according to the invention via an intermediate adapter.

The connection area of the ampoule can be an external thread which meshes with a correspondingly sized internal thread of the ampoule holder, or it comprises one or more pairs of protruding buttons of a bayonet lock or an annular bead or groove of a plug-in closure.

The connection area is usually formed in the vicinity of an outflow opening of an inserted ampoule or in the vicinity of a location intended to accommodate such an outflow opening. For example, the ampoule can have a hollow cylindrical end, in which the end face is intended to accommodate an outflow opening and on the lateral surface as a connecting means an external thread of a screw cap, a pair of buttons of a bayonet lock, an annular bead or an annular groove of a plug-in fastener may be present.

The outflow opening is only cut or punched into the material of the ampoule by means of the opening device when the ampoule is connected according to the invention. The ampoule is still completely closed and sealed before insertion and connection, which prevents contamination or loss of fluid.

The shape of the ampoule as well as the connection area or the opening are in principle arbitrary. However, for reasons of minimizing the amount of material required for a given liquid volume, a rotationally symmetrical ampoule shape, in particular a spherical or at least a hollow cylindrical shape, is recommended. To achieve the best possible seal, a round opening is recommended, as this minimizes the circumference to be sealed for a given opening area.

For this purpose, the area that comes into contact with the opening device must consist of sufficiently soft and cuttable material, for example plastic or thin metal. The rest of the ampoule, including the connection area, can either be made of the same material, although possibly with different wall thicknesses, the area in which the opening is to be cut being advantageously made thinner in order to make connecting the ampoule easier and also a to guarantee a cleanly defined opening. This is important for the tightness of the connection between the ampoule and the nebulizer, especially if this is only due to the positive fit between the ampoule and the nebulizer Opening and the opening device comes about. The rest of the ampoule can also be made from one or more other materials. It is conceivable here to provide a stronger, more stable material such as glass or metal. The ampoule can, for example, be designed as a glass bottle which is closed at an upper end with a seal made of metal foil or plastic.

In any case, the design of the nebulizer unit and ampoules according to the invention eliminates the need for additional moving parts and mechanisms that were previously required for inserting and connecting ampoules. The nebulizer unit according to the invention is therefore, on the one hand, simpler and much more cost-effective to manufacture, which shortens the “amortization period” from the user's perspective, and, on the other hand, it is also constructed in a much less angled manner, so that cleaning and sterilization are simplified. This ensures that there is no or only a very low level of germ contamination over a period of use of one to two weeks, or a maximum of one month.

After this period, the nebulizer unit should be discarded and replaced with a new one. Due to the cheaper production, this would also be financially acceptable for the majority of users, which significantly increases the chance that this recommendation will actually be followed.

The use of the nebulizer unit according to the invention involves inserting a provided ampoule filled with medication liquid into the ampoule holder of the nebulizer as intended and through the interaction of the Connecting means of the ampoule holder with the connection area of the ampoule to the nebulizer unit, so that the outflow opening of the ampoule, which according to the present invention was only created when it was inserted/connected by the opening device, is brought into line with the inlet opening or openings of the opening device and connected in a liquid-tight manner.

Depending on the type of connection means and the connection area, different movement sequences would be required from the user. A simple friction connection between the ampoule and the ampoule holder is the simplest conceivable solution. Plugging and connecting would then be possible in one go through a straight plugging movement. If the ampoule holder is rotationally symmetrical, additional rotation is also possible when inserting it, which can be advantageous, for example, to support the opening or cutting effect of the opening device.

A screw cap, in which an external thread of the ampoule meshes with an internal thread of the ampoule receptacle, requires that the user places the ampoule in a manner known per se with the end of the thread on the internal thread of the ampoule receptacle and screws it into it with rotary movements, the ampoule is cut open by the opening device at the designated location, for example an area around the axis of rotation on a front end face.

With a bayonet lock, it would first be necessary to insert it in a straight line, followed by a rotational movement, whereby the buttons, which can be formed on the outside of the ampoule or the inside of the ampoule holder, must first be aligned with the slots. The course of the slots accordingly has an axially directed section followed by a mainly tangential section, the latter of which may well have a non-vanishing angle with the tangential direction in order to support the cutting process, for example.

A plug-in closure with a cooperating annular bead and annular groove requires a straight insertion movement, but with a rotationally symmetrical design it also allows a rotational movement that supports the cutting process through the opening device.

"Annular bead" or "annular groove" as used herein means any circumferential bump or depression, regardless of whether it has a circular, oval, polygonal or other cross-section.

The production of the nebulizer unit according to the invention is simplified and accelerated by being composed of two essential components: a front part, which houses the aerosol generator and includes connection options for coupling components such as T-pieces or a mouthpiece, and a rear part, which includes the ampoule holder and opening device.

To produce a nebulizer unit according to the invention, both parts are prepared by molding from appropriate material and, if necessary, installing the components in a manner known per se. Then they are put together and either detachably or non-detachably connected. The former can be done by pressing or plugging together (positive and/or frictional fit), screwing, the latter by gluing or welding.

Advantageous developments of the present invention, which can be implemented individually or in combination, provided they are not obviously mutually exclusive, will be described below.

The connecting means of the ampoule holder and the connecting region of the ampoule interacting therewith preferably form a screw cap, in which the ampoule holder has an internal thread and the connecting region has an external thread meshing with it. Alternatively, the ampoule is preferably fastened in the ampoule receptacle by means of a bayonet lock, with the pins or buttons protruding into the interior of the ampoule receptacle as part of it or, particularly preferably, as part of the connection area of the ampoule. The slots that interact with the pins or buttons are accordingly made in the other part, particularly preferably in the ampoule holder.

The course of the slots has at least two areas according to known bayonet locks: a first, essentially axially oriented area and a further, essentially tangentially oriented area. Furthermore, the present invention preferably proposes to provide an area between these two with an angle to the tangential direction of 5 to 30 degrees, particularly preferably 10 to 20 degrees. This will achieved that when inserting and connecting the ampoule, an axial movement is superimposed on the tangential movement in this intermediate area. This can advantageously involve the squeezing, ie the partial compression, of the ampoule by a squeezing device, in the simplest case a narrowing in the cross section of the ampoule holder. When inserting the pins in the connection area of the ampoule into the axial part of the corresponding slots of the ampoule holder, there is preferably no or only a slight crushing and the main crushing occurs in the course of the rotation and axial displacement of the ampoule while it passes through the central, angled slot region.

Another preferred alternative is to establish the connection between the ampoule and the nebulizer unit using a plug-in closure. This included a circumferential annular groove and a corresponding annular bead. The cross section of the bead is preferably larger than that of the ampoule holder in the upper area, which guarantees that the ampoule will not be crushed when it is inserted and connected.

The present invention proposes that, in one embodiment, the opening in the opening device, through which the medication liquid flows from the ampoule into the nebulizer unit, communicates with the chamber located directly in front of the aerosol generator via a supply channel. This creates more freedom in the structural design of the nebulizer unit, since the orientation of the ampoule holder and the opening device present therein is independent of the orientation of the aerosol generator. The fluid one Communication between the two is always ensured through the supply channel.

However, according to the present invention, the feed opening of the opening unit is in direct communication with the feed chamber, i.e. without the interposition of a feed channel, since this enables a minimal volume to be filled and, accordingly, a smaller sized squeezing device or opening device with a displacement effect is already sufficient.

The opening device of the nebulizer unit according to the invention with an ampoule is preferably a mandrel which has at least one feed opening which is in fluid communication with the feed chamber located in front of the aerosol generator. More than one such feed opening is particularly preferably present. This means that a given or desired overall opening cross section can be achieved with small opening radii at the same time.

The term 'thorn' here is intended to imply that its top is inclined, so that it is longer or higher on one side than on another, for example the opposite side. The top side can be flat or, particularly preferably, concavely curved. This makes the tip of the mandrel more prominent and improves its cutting action.

Furthermore, the opening device, which defines a direction through its opening, can have a different orientation than the aerosol generator. This direction can be perpendicular to the aerosol generator. The opening device is preferred however, oriented at an angle between 30 and 60 to the aerosol generator. This allows capillary effects to be minimized and ensures that the medication liquid flows out of the ampoule as quickly and completely as possible. When designing the ampoule, care must be taken to ensure that when the nebulizer is in a standard or prescribed position for inhalation, usually such that the nebulizer is essentially horizontal, none of the inner surfaces of the ampoule have a tangential surface that is parallel to the horizontal one.

The present invention proposes, as a further design option, to supplement or replace a crushing of the ampoule with an opening device designed as a displacer. In this case, the opening device would be designed with an increased volume compared to the previously mentioned versions. When the ampoule is connected, this enters the interior and displaces any medication liquid present there out of the ampoule and into the feed chamber through the feed opening or openings of the opening device. Such a configuration has the further advantage that it also offers the possibility of increasing the contact area between an outside of the opening device and the inner wall of the ampoule, which benefits the tightness and stability of the connection.

The nebulizer unit also has an aerosol chamber on the side of the aerosol generator opposite the supply chamber, which has an outlet opening. Various coupling parts, such as mouthpieces for direct inhalation, are attached to this outlet opening for the aerosol or T-pieces of a ventilation system can be connected. For example, the housing part forming the aerosol chamber can be designed as a hollow cylinder in the form of a connecting piece.

The present invention provides for the nebulizer unit to be composed of a front and a rear part. The former includes the aerosol generator, as well as the aerosol chamber and connection options for coupling pieces. The rear part includes the ampoule holder with opening device and the feed chamber on the feed side of the aerosol generator or at least its rear part. The two parts are brought together and connected to one another during the production of the nebulizer unit according to the invention. In the simplest case, the connection is ensured by friction. However, a more sophisticated releasable connection option such as a plug-in fastener comprising a groove and bead or tongue and groove, a bayonet fastener or a screw fastener can also be provided. However, it is particularly preferred to connect the two parts in a non-detachable manner by gluing or welding them after they have been plugged together. This guarantees the best possible seal and means there is no need for additional sealing materials, such as sealing rings on a contact surface between the front and rear parts. The housing of the nebulizer unit according to the invention is preferably made of plastic, in particular a thermoplastic material, by injection molding. Laser welding or ultrasonic welding are therefore possible welding methods.

In addition to the pure connection and connection function, the ampoule holder also has a guiding and holding function for the ampoule. In order to better perceive these, the present invention proposes to equip them with ampoule guides that are shaped complementary to the ampoule.

Furthermore, according to the invention, a squeezing device is present in the ampoule holder, which is able to squeeze the ampoule when it is inserted and connected, so that an excess pressure is built up inside, which is sufficient to release a quantity of the ampoule through the opening device after it has been opened, in particular by cutting it open or punched open To squeeze medication liquid out of the ampoule, which corresponds to the volume of the feed chamber and, if necessary, the feed channel. The squeezing device can, for example, consist of knobs or a bead protruding into the interior of the ampoule holder, or can also be provided in a continuously tapering cross section of the ampoule holder.

The sealing of the connection between the ampoule and the nebulizer unit is preferably ensured by a fit of the ampoule that is as precise as possible, with the outflow opening of the ampoule tightly surrounding the opening device. The fact that the area into which the opening device cuts the outflow opening in the wall of the ampoule is made of flexible material contributes to a liquid-tight fit.

The precise fit could be advantageously supplemented or the requirements on it reduced if additional sealing means, for example in the feed openings of the opening device enclosing sealing ring, which is flush with one end face of the ampoule.

The ampoule of the nebulizer unit according to the invention with ampoule is preferably made at least in sections from a flexible, easily cut, but sufficiently strong and stable material, in particular a plastic. This is particularly true for the area where the outflow opening is to be created. This is preferably generated by the opening device when inserting and connecting the ampoule according to the invention. Alternatively, the ampoule can also have a break-off tab in the area of the future outflow opening, in particular at its lower end, which a user breaks off before inserting it. Leakage of medication liquid would be ensured by a slight negative pressure in the ampoule.

Furthermore, the ampoule preferably has a circular cross section and is particularly preferably shaped rotationally symmetrically at least in the part inserted into the ampoule holder. In particular, the ampoule according to the invention is roughly hollow-cylindrical in shape before insertion. At the upper end, the ampoule is also preferably provided with an ergonomically shaped, handle-like thickening for easier gripping and screwing.

The disclosed use provides that an ampoule filled with medication liquid is provided and inserted with the connection area first into the ampoule holder of the nebulizer unit according to the invention and connected according to the respective embodiment of the closure. The insertion and connection process is carried out at the same time using the opening device produces an outflow opening in the wall of the ampoule, in particular an end face, for example cut or punched into it. By pressing the opening device into the opening that forms during cutting or punching and completely filling it, sealing against the outside space is ensured. The medication liquid can only flow into the feed chamber in front of the aerosol generator through the feed openings present in the opening device.

Furthermore, the present invention is preferred if this outflow is supported by the creation of an overpressure inside the ampoule, namely by squeezing an ampoule made of sufficiently flexible material and / or by displacing the liquid from the interior of the ampoule by means of a correspondingly more voluminous design, further in the opening device protruding into the ampoule. The latter offers the advantage that it can also be used with ampoules made of stiff material, such as glass or metal.

The manufacturing method according to the invention includes the provision of a front part comprising the aerosol generator and a rear part comprising the ampoule holder and opening device. These are then assembled and connected in a detachable or non-detachable manner, with a non-detachable connection being preferred for reasons of tightness and hygiene. A detachable connection can be achieved by friction, bayonet, plug or screw connection. For a non-detachable connection, the present invention suggests gluing or, preferably, welding.

Further properties, features and advantages of the present invention result from the exemplary embodiments explained in more detail in the following appendix to the figures. These are only intended to illustrate the invention and in no way limit its generality.

Figur 1:

Eine Ausführungsform einer erfindungsgemäßen Verneblereinheit mit einschraubbarer Ampulle.

Figur 2:

Eine weitere Ausführungsform einer erfindungsgemäßen Verneblereinheit mit per Bajonettverschluss befestigter Ampulle.

Figur 3:

Eine weitere Ausführungsform einer erfindungsgemäßen Verneblereinheit mit per Steckverschluss befestigter Ampulle.

Figur 4:

Herstellung einer Ausführungsform der erfindungsgemäßen Verneblereinheit mit Ampulle aus Vorderteil und Rückteil.

Show it:

Figure 1:

An embodiment of a nebulizer unit according to the invention with a screw-in ampoule.

Figure 2:

Another embodiment of a nebulizer unit according to the invention with an ampoule attached with a bayonet lock.

Figure 3:

Another embodiment of a nebulizer unit according to the invention with an ampoule attached by a plug-in closure.

Figure 4:

Production of an embodiment of the nebulizer unit according to the invention with an ampoule consisting of a front part and a back part.

Figure 1 shows a longitudinal section through an embodiment of the nebulizer unit according to the invention with an ampoule. Housing 10 consists of front part 10' and rear part 10". The front part 10' houses aerosol generator 101, on the feed side of which there is feed chamber 17, in which the medication liquid wets the back of the aerosol generator before atomization. On the output side is the aerosol chamber 15 with outlet opening 150, which is enclosed by an area of the housing part 10 'that is essentially shaped as a hollow cylinder. This shape makes this part suitable for coupling with coupling pieces such as a mouthpiece or also suitable for a T-piece of a ventilation system. The rear boundary of the chamber 17 is formed by an end face of the rear part 10". The feed opening 180 of the opening device 18, which, like the ampoule holder 19, belongs to the rear part 10", opens into this boundary. Ampoule receptacle 19 includes an internal thread as connecting means 19, which meshes with an external thread 201 as a connection area of an inserted ampoule 20 and thus holds the ampoule firmly in the ampoule receptacle. Opening device 18, a mandrel with a flat top and a concentric opening, is touched on the reverse by the inner edge of the outflow opening 200 of ampoule 20, so that a firm and tight fit is guaranteed.

The ampoule 20 with medication liquid 30 is essentially rotationally symmetrical and, in this embodiment, has a thickening 202 at the top that serves as a handle and a break-off tab 203 at the bottom. If a user removes the break-off tab 203, an outflow opening 200 is created, the dimensions of which correspond to the external dimensions of the opening device 18.

Figure 2 shows a longitudinal section through an alternative embodiment of the nebulizer unit according to the invention with an ampoule. Ampoule 20 is attached by means of a bayonet lock, in which the pins represent the connection means 191 of the ampoule holder 19. The pins engage in slots 201 in the ampoule 20, which each have an axial first and a tangential second section, so that the corresponding movement indicated by the double arrow is necessary for inserting and connecting the ampoule 20. Ampoule holder 19 is extended beyond the pins 191. This Part 192 is used to guide and securely hold ampoule 20. Here too, the housing comprises a front part 10' and a rear part 10". Opening device 18 is a mandrel with a curved top, so that the tip protrudes more prominently and the wall is lighter can cut into the front side of ampoule 20 to create outflow opening 200. Squeezing device 193 presses or squeezes the front part of the ampoule in order to create an excess pressure inside, which removes a portion of the liquid 30 corresponding to the volume of the feed chamber from the interior of ampoule 20 pushes out.

In Figure 3 Another embodiment of the nebulizer unit according to the invention with an ampoule is shown in longitudinal section, in which the ampoule is held by means of a plug-in closure. An annular bead 191 in the ampoule holder serves as a connection means, which interacts with the annular groove 201 in the connection area of the ampoule 20. Ampoule 20 has a thickened end in order to avoid unpleasant point pressure on a user's hand when inserting the ampoule and also to offer a better opportunity for attack when pulling it out. Opening device 18 is also designed here as a mandrel with a curved top, but is significantly more voluminous than other designs. As a result, it can serve as a displacer, which displaces a quantity of medication liquid 30 from the interior of ampoule 20 and into the supply chamber 17 via outflow opening 200, supply opening 180 and supply channel 16. This allows the use of ampoules made of little or non-flexible material such as glass or metal, which are non-destructive Crushing is not possible. Sealing ring 194 lies enclosing the opening 200 at the lower end of the ampoule 20 and, in addition to the precise fit on the opening device 18, prevents medication liquid from escaping.

Figure 4 shows in two steps an embodiment of the production of a nebulizer unit according to the invention from a front and a rear part. The separately manufactured parts 10', 10" are assembled and welded at the contact point to form a tightly closing, hygienically enclosing housing 10. Front part 10' holds aerosol generator 101 in its interior. As with all other embodiments shown, the outlet-side section is part of the housing 10' is manufactured as an approximate hollow cylinder and allows the connection of coupling parts such as mouthpieces or T-pieces. The rear housing part 10" includes an ampoule holder with connecting means 191, here in the form of an internal thread of a screw cap, which also serves as an ampoule guide 192.

Reference character list

1

Nebulizer unit

10

Housing

10'

Front part

10"

Back part

101

Aerosol generator

15 16

feed channel

17

Feed chamber

18

Opening device

180

feed opening

19

Ampoule intake

191

Connection means

192

Ampoule guide

193

Crushing device

194

sealing ring

20

ampoule

200

Outlet opening

201

Connection area

202

Handle

203

tab

30

medication liquid

Claims (13)

1. A nebulizer unit with an ampoule, comprising

   - a housing (10) which encases an aerosol generator (101) with a feeding chamber (17) lying on one side,

   - an ampoule receiver (19) with a squeezing device (193),

   - an opening device (18) with a least one opening (180) which is in communication with the feeding chamber (17), and

   - an ampoule (20) with liquid (30), which possesses at least one opening (200) with which it is inserted or insertable into the ampoule receiver,

   whereby the ampoule (20) has a connection region (201) that cooperates with connection means (191) of the ampoule receiver (19) to firmly retain the ampoule (20) in the ampoule receiver (19) and to sealingly connect the openings (200) and (180), and

   whereby the housing (10) is made up of a front part (10`) that comprises the aerosol generator (101) and a rear part (10") that is separate from the front part (10`) and comprised the ampoule receiver (19), and whereby the squeezing device (193) is suitable for squeezing the ampoule (20) during its insertion, thereby creating an excess pressure in the ampoule (20),

   whereby the opening device (18) is integrated into the rear part (10"), and

   the squeezing device (193) is furthermore designed to squeeze the ampoule (20) during its insertion and hold it squeezed in the inserted state in such a way, that in an interior of the ampoule (20) an excess pressure is built which is sufficient to push, after the ampoule (20) has been opened by the opening device (18), an amount of medicament liquid corresponding to a volume of the feeding chamber and, if applicable, a feeding channel out of the ampoule (20).
2. The nebulizer according to claim 1, characterized in that the connection region (201) and the connection means (191) are

   - an outer and an inner thread of a screw closure,

   - pins and slots of a bayonet lock, or

   - a ring bead and a ring groove nut of a plug-in closure.
3. The nebulizer according to claim 1 or 2, characterized in that the opening (180) in the opening device (18) communicates with the feeding chamber (17) via a feeding channel (16).
4. The nebulizer unit according to one of the proceeding claims, characterized in that the opening device (18)

   - is a mandrel, in particular a mandrel with a curved top, and/or

   - possesses more than one opening (180).
5. The nebulizer unit according to one of the proceeding claims, characterized in that the opening device (18) has a different orientation than the aerosol generator (101), preferably is oriented in an angle of between 30 and 60 degrees, in particular in an angle of 45 degrees relative to the aerosol generator.
6. The nebulizer unit of claim 5, characterized in that the opening device (18) is of such size that in the completely inserted state of the ampoule (20) a partial volume of the opening device protruding into the ampoule is slightly larger than a volume of the feeding chamber (17).
7. The nebulizer unit according to one of the proceeding claims, characterized in that the front part (10') and rear part (10") are connected

   - releasably, in particular by screwing or plugging, or

   - non-releasably, in particular by glueing or welding, like laser or ultrasound welding.
8. The nebulizer unit according to one of the proceeding claims, characterized in that the squeezing device (193) consists of nubs or a bead protruding into the interior of the ampoule receiver (19) or is a continuously tapering cross-section of the ampoule receiver (19).
9. The nebulizer unit according to one of the proceeding claims, characterized in that the seal between the ampoule opening (200) and the ampoule reveiver (19) or the opening device (18) is ensured by a sealing means, in particular one or several gaskets, and/or through a perfect fit of the opening (200) on the opening means (18).
10. The nebulizer unit according to one of the proceeding claims, characterized in that the ampoule (20) has at its upper end a bulge (202) serving as a grip.
11. The nebulizer unit according to one of the proceeding claims, characterized in that the ampoule (20)

    - has, when inserted into the nebulizer and given the prescribed optimal orientation of the nebulizer unit, only tangential planes to the surface of its interior volume which form an angle of greater than 0 degrees with the horizontal, and/or

    - has a break-off tab at its lower end, and/or

    - is made at least partially from a flexible material, particularly a plastic, and/or

    - has a circular cross-section, and/or

    - a rotationally symmetrical shape, and/or

    - a roughly hollow-cylindrical shape when not inserted.
12. A method for making a nebulizer unit according to one of the proceeding claims, characterized in that

    - a front part (10`) with an aerosol generator (101) and a rear part (10") which is separate from the front part (10') and has an ampoule receiver (19) and an oppening device (18) are provided,

    - assembled, and

    - connected to each other in a releasable or non-releasable fashion.
13. The method according to the proceeding claim, characterized in that the connection of the front part (10`) and the rear part (10") is effected through

    - a friction closure, and/or

    - through a bayonet-, plug- or screw closure, and/or

    - by glueing and/or welding, in particular laser or ultra sound welding.

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